CVT-301 in Subjects with Parkinson's Disease

• Research type

  Research Study

• Full title

  A Randomized, Placebo-Controlled Phase 2 Study of the Safety, Pharmacokinetics, and Pharmacodynamics of CVT-301 (Levodopa Inhalation Powder) in Patients with Parkinson’s Disease and Motor Response Fluctuations (“Off” Episodes)

• IRAS ID

  100418

• Contact name

  Donald Grosset

• Sponsor organisation

  Civitas Therapeutics, Inc.

• Eudract number

  2012-000181-37

• Research summary

  This is a Phase 2, multi-centre study designed to assess the safety and drug effects of levodopa inhalation powder (CVT-301) in patients with Parkinson's disease. 24 participants will be enrolled in this study. CVT-301 is an inhaled form of levodopa, a medication that has been used for many years to treat patients with Parkinson's disease. CVT-301 is intended to help provide more rapid relief for "off" episodes (times of sudden loss of muscle control and onset of Parkinson Symptoms). All participants meeting eligibility criteria will receive oral levodopa/carbidopa, low dose of inhaled levodopa, high dose of inhaled levodopa or placebo. Patients will be enrolled in this study for about 6 to 12 weeks.

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  12/NW/0143

• Date of REC Opinion

  11 Apr 2012

• REC opinion

  Further Information Favourable Opinion